ICH Document Structure, a Call for Change

The International Conference for Harmonization (ICH) has guidelines categorized into four main categories:

1. Quality (Q) Guidelines focus on the chemical, pharmaceutical, and biological quality standards, including stability testing protocols to ensure the longevity and consistency of drug products.
2. Safety (S) Guidelines address non-clinical and preclinical safety evaluations, guiding the toxicological assessments necessary to protect patients’ health.
3. Efficacy (E) Guidelines cover the clinical aspects of pharmaceutical development, providing standards for designing, conducting, and analyzing clinical trials to ensure therapeutic benefits.
4. Multidisciplinary (M) Guidelines encompass guidelines that do not fit neatly into the other categories, dealing with genomics, terminologies, and technical aspects of drug registration.

Any Q document is instantly and rightly viewed as a GMP guideline. This includes the quality trio, which, while they have a good philosophy, are still written specifically for GMP purposes. So, if you write your paper, good practice guide, standard, article, or what-have-you and refer heavily to the Q trio, you are either writing a GMP-centered piece or losing most of your audience.

The frustrating thing is that quality-by-design (Q8), risk management (Q9), and quality system management (Q10) are core concepts that apply across the pharmaceutical lifecycle, and there are best practices across all three that can and should be universal, especially Q9(r1), which can really better define risk management as defined in E6, and Q10, which can really shore up parts of E8.

What I would love to see the ICH do is write a technical reference document on risk management. Then, E6 and Q9 would have specific implementation aspects related to their focus. Put all the shared approaches in one place and build on them. The amusing thing is that they are already doing that. For example, Q13 applies the Q trio to continuous manufacturing, and Q14 applies it to the analytical lifecycle.

But for now, if you are writing and just referring to Q9 and Q10 don’t be surprised when all your clinical and safety colleagues tune you out.